A medicine which has not received marketing authorisation in Belgium or in another member state of the European Union can be exported as long as one obtains a declaration for export (Dutch or French) from the Minister or his representative (chief executive of AFMPS / FAMHP).
The request for a declaration for exporting a medicine for veterinary use (Dutch or French) must contain the information and documents mentioned in § 1 of article 245 of the Royal Decree dated 14/12/2006 (French version) (part 1 - part 2) relating to medicines for human and animal use. It must be sent electronically to the FAMHP.
Each email can only contain one declaration request (1 email per declaration) and must clearly indicate the subject 'ED' and the name of the concerned medicinal product. The application must contain the different documents requested, separately (1 document = 1 file attached). Applications must be sent from the mailbox of the qualified person (QP), the responsible person or the legal representative of the company and must contain an extension specific to the company (hotmail addresses, gmail, skynet, ... will not be accepted). They must be sent to the generic address : D-EDfirstname.lastname@example.org.
The Minister or his representative communicates his decision to the applicant within 60 days from the date the request was submitted. He can demand additional information. In that case the 60-day timeframe is suspended until the requested information is supplied. The declaration for export is valid for 5 years.
The declarations for export are subject to a payment. More information about fees can be found here. The overview regarding declarations for export is only available in Dutch or French. An invitation to pay the amount will be sent to you by the FAMHP via an invoice.
Federal Agency for Medicines and Health Products
DG Inspection - Division authorisations - Cell authorisations, Declarations and Certificates
General telephone number: